Structured and secured eCRFs were developed for the study. All patients are assigned to a study identification number. Identifiers are removed from the data. Rigorous data quality assurance processes includes initial and follow-up data management training; online edit checking during web-based data entry; programmed logic checks against the pooled data repository and remote and on-site monitorings of a random sample of source documents against the submitted data throughout the data collection process to ensure the accuracy of the data used.
At every visit, the CRN reviews the patient booklet and after a patient interview annotates the clinical data accordingly. Data collected not only include concomitant medications, general information such as smoke, alcohol, hospitalisation, medical or paramedical consultations, paraclinical data such as left ventricular ejection fraction LVEF , bone densitometry information, haematological and biochemical standard evaluation but also detailed toxicity information on arm and breast morbidity and focused on specific areas of interest such as gynaecology, rheumatology, haematology, cardiology, pneumology, gastroenterology and dermatology.
Blood test and physiological evaluation including complete blood count, platelets, liver function assessment, ionogram, creatinaemia, glycaemia, cholesterolaemia, triglyceride level determination are performed at inclusion, M0, M36 and M In premenopausal women, evaluation of the ovary function and follicle reserve: follicle-stimulating hormone, luteinizing hormone, oestradiolaemia are performed at M0 and M Bone densitometry is performed in postmenopausal patients at diagnosis regardless of the hormone receptor status, as well as in all patients treated by aromatase inhibitors at inclusion, M36 and M Other mandatory examinations to be performed in case of clinical signs of chronic toxicity: echography or myocardial scintigraphy in case of dyspnoea or other signs indicating the possibility of cardiac impairment, ECG in case of palpitations, pelvic echography and if needed hysteroscopy in case of metrorrhagia.
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In addition, a work questionnaire is performed 24 months after end of treatment M Table 1 details schedule of these patient-reported outcome measures. Specimens are collected on fasting. Examples of biological substudies ongoing in CANTO include 1 microbiota that aims to determine the role of the intestinal flora microbiota in response to chemotherapy and 2 CANTO-COG that aims to evaluate the cognitive impact of treatment-related toxicity.
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For all substudies, a specific approval from regulatory entities and ethics committee is required and separate written informed consent. The study is expected to have enough power to examine associations with treatment-related toxicities. Enrolment started in , and by October , 12 patients were enrolled. A first data lock was performed after the patients were enrolled and have reached M At inclusion, Table 2 includes selected study population characteristics of the first women enrolled in CANTO intermediate cohort. The vast majority of patients had hormone receptor-positive tumours By October , almost 12 French patients with breast cancer were recruited and will be followed in the CANTO cohort for a minimum of 5 years.
There is a minimal missing clinical data collection and high rate of patient-reported outcome completion rate.
Millions of women are breast cancer survivors and a substantial proportion suffers from long-term treatment-related toxicities. Most of the cohorts of breast cancer survivors are not representative of the overall population eg, single institutional studies, studies that only include patients covered by specific insurance programme and are lacking in comprehensiveness and completeness ie, lacking detailed clinical, treatment information, patient-reported outcomes including psychological, functional and social impact and biological samples. CANTO tried to address these limitations.
CANTO participants are from 26 centres distributed across France that will be followed for a minimum of 5 years with longitudinal data collection. CANTO followed standard methodological quality criteria for observational studies. It is registered in public repositories. It implemented data quality procedures. It has few missing data for measures of interest; the patient population has well-described inclusion and exclusion criteria; the outcomes of interest are well characterised, the length of observation has sufficient duration to capture treatment-related toxicity and the sample size was calculated based on defined hypotheses.
In addition, CANTO consists of a dedicated and engaged national network, and therefore, the CANTO sites can subsequently put in place practical solutions devised for this patient population. We acknowledge some limitations. First, CANTO focuses on women diagnosed and followed in France with early breast cancer and therefore may not be generalisable to all women including women in other countries as well as women with advanced disease.
Although it covers a substantial proportion of French cancer centres, it is not a population-based sample. Second, we do not have a healthy comparison population, but we will be able to explore the range of toxicities severity in patients with cancer across a variety of treatment intensities, using instruments that were validated among patients with cancer. Third, as with all prospective studies with quality of life endpoints, there is a risk of biased statistical inference with missing data and we will adhere closely to standards put forth by the US National Research Council.
The CANTO cohort, in addition with recent assembled survivorship cohorts, 7—10 represent a major opportunity to better understand long-term treatment-related toxicity on cancer survivors, having the statistical power needed to make potential new discoveries about causes, mediators and moderators of treatment-related toxicities and providing light on avenues to diminish the impact of toxicities among survivors. Contributors Al authors contributed to the conception and design, acquisition of data, analysis and interpretation of data, drafting the manuscript or revising it critically for important intellectual content, gave final approval of the version to be published and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Other authors: no relationships to disclose. Ethics approval The study was approved by French regulatory authorities 14 September and French ethics committee 14 October Provenance and peer review Not commissioned; externally peer reviewed. You will be able to get a quick price and instant permission to reuse the content in many different ways.
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Article Text. Article menu. Abstract Background Corresponding with improved survival among patients with breast cancer, the awareness of the long-term effects of cancer treatments has increased. Statistics from Altmetric. Methods Study design and organisational structure Study design CANTO is a French longitudinal prospective multicentre cohort study of women with localised, stage I—IIIA breast cancer receiving their primary breast cancer care at one of the 26 participating French cancer centres.
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Study population Patients with the following characteristics are eligible for inclusion: 1 have a proven invasive breast cancer, 2 cT0-cT3, cN tumour by American Joint Committee on Cancer AJCC seventh edition, 14 3 18 years old or older at diagnosis, 4 untreated at the time of inclusion including surgery , 5 fluent in French and 6 able to provide written, informed consent. Study measures and collection procedures Main procedures Table 1 summarises data measures and schedule of data collection.
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Table 1 Data measures and schedule of data collection. Quality of procedures Rigorous data quality assurance processes includes initial and follow-up data management training; online edit checking during web-based data entry; programmed logic checks against the pooled data repository and remote and on-site monitorings of a random sample of source documents against the submitted data throughout the data collection process to ensure the accuracy of the data used.
Paraclinical measures Blood test and physiological evaluation including complete blood count, platelets, liver function assessment, ionogram, creatinaemia, glycaemia, cholesterolaemia, triglyceride level determination are performed at inclusion, M0, M36 and M Power consideration and data analysis The study is expected to have enough power to examine associations with treatment-related toxicities. Data quality metrics Enrolment started in , and by October , 12 patients were enrolled. Population clinical and treatment characteristics Table 2 includes selected study population characteristics of the first women enrolled in CANTO intermediate cohort.
Discussion By October , almost 12 French patients with breast cancer were recruited and will be followed in the CANTO cohort for a minimum of 5 years. Conclusions The CANTO cohort, in addition with recent assembled survivorship cohorts, 7—10 represent a major opportunity to better understand long-term treatment-related toxicity on cancer survivors, having the statistical power needed to make potential new discoveries about causes, mediators and moderators of treatment-related toxicities and providing light on avenues to diminish the impact of toxicities among survivors.
References 1. Cancer statistics, CA Cancer J Clin ; 64 : 9 — Mammography screening and risk of breast cancer death: a population-based case-control study. Cancer Epidemiol Biomarkers Prev ; 21 : 66 — J Clin Oncol ; 34 : — Fatigue in breast cancer survivors: occurrence, correlates, and impact on quality of life. Three other health officials from the hospital, the social security and the local health authority, are also in the dock accused of not assisting someone in danger.
Dozens of patients are expected to give evidence in the case, which began on Monday and is due to last until the end of October. Those too sick to attend the court hearing will give evidence by video link.
The errors were blamed on the radiation machines being upgraded with new ones and doses of radiation being miscalculated. At the correctional court in Paris the victims, most of whom have already received financial compensation, hope their suffering will be finally recognised. Defending one of the accused, lawyer Jean Reinhart said his client wanted to "help the court understand what happened".